510(k) · Cleared
ClearedVivix-S 1012N
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vieworks Co., Ltd. · MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Cleared on Feb 26, 2016 as substantially equivalent to K122866 (Vieworks Co., Ltd., 2013) and 1 other predicate after a 150-day review. Its family tree reaches back 7 generations to 1981. 5 later devices descend from it.
- Decided
- Feb 26, 2016
- Review
- 150 days
- Class
- Class II
- Product code
- MQB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K803130 (1981). 25 ancestors in all. 5 later devices descend from it, 1 citing it directly.
- Root · 7 generations backK803130 Multix U. Bucky Table X-Ray UnitSiemens Corp. · 1981 · Recalled
- 6 generations backK971452 Multix Top/Pro Radiographic X-Ray TableSiemens Medical Solutions USA, Inc. · 1997 · Recalled
- 5 generations backK983732 Thorax FD and Multix FDSiemens Medical Solutions USA, Inc. · 1999 · Recalled
- 4 generations backK992794 Stingray DR, Model 1Infimed, Inc. · 1999
- 3 generations backK024147 Paxscan 4030 Medical Digital Imaging SystemVarian Medical Systems, Inc. · 2003
- 2 generations backK120020 Vivix-SVieworks Co., Ltd. · 2012
- 1 generation backK122866 Vivix-S with VxvueVieworks Co., Ltd. · 2013
- This deviceK152855 Vivix-S 1012NVieworks Co., Ltd. · 2016
- Descendant · cites it directly · 4 of its ownK200418 Vivix-S VWVieworks Co., Ltd. · 2020
- Descendant · 2 generations on · 2 of its ownK221512 Vivix-S FW (Model: FXRD-2530FAW, FXRD-3643FAW, FXRD-4343FAW)Vieworks Co., Ltd. · 2022
- Descendant · 2 generations on · 1 of its ownK241980 !M1Solutions For Tomorrow AB · 2025
- Descendant · 3 generations on · 0 of its ownK251710 Mobile X-ray unit (!M1)Solutions For Tomorrow AB · 2025
- Descendant · 2 generations on · 0 of its ownK211790 DX-D Imaging Package with XD DetectorsAgfa N.V. · 2021
Most influential descendants
Showing 5 of 5 · See all- K200418Vivix-S VWVieworks Co., Ltd. · 2020 · cites it directly4descendants
- K221512Vivix-S FW (Model: FXRD-2530FAW, FXRD-3643FAW, FXRD-4343FAW)Vieworks Co., Ltd. · 2022 · 2 generations on2descendants
- K241980!M1Solutions For Tomorrow AB · 2025 · 2 generations on1descendant
- K251710Mobile X-ray unit (!M1)Solutions For Tomorrow AB · 2025 · 3 generations on0descendants
- K211790DX-D Imaging Package with XD DetectorsAgfa N.V. · 2021 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K803130 | Multix U. Bucky Table X-Ray Unit | Siemens Corp. | 1981 | 1 |
| −6 | K971452 | Multix Top/Pro Radiographic X-Ray Table | Siemens Medical Solutions USA, Inc. | 1997 | 8 |
| −5 | K983732 | Thorax FD and Multix FD | Siemens Medical Solutions USA, Inc. | 1999 | 1 |
| −4 | K992794 | Stingray DR, Model 1 | Infimed, Inc. | 1999 | — |
| −3 | K024147 | Paxscan 4030 Medical Digital Imaging System | Varian Medical Systems, Inc. | 2003 | — |
| −2 | K120020 | Vivix-S | Vieworks Co., Ltd. | 2012 | — |
| −1 | K122866 | Vivix-S with Vxvue | Vieworks Co., Ltd. | 2013 | — |
| 0 (this device) | K152855 | Vivix-S 1012N | Vieworks Co., Ltd. | 2016 | — |
| +1 | K200418 | Vivix-S VW | Vieworks Co., Ltd. | 2020 | — |
| +2 | K221512 | Vivix-S FW (Model: FXRD-2530FAW, FXRD-3643FAW, FXRD-4343FAW) | Vieworks Co., Ltd. | 2022 | — |
| +2 | K241980 | !M1 | Solutions For Tomorrow AB | 2025 | — |
| +3 | K251710 | Mobile X-ray unit (!M1) | Solutions For Tomorrow AB | 2025 | — |
| +2 | K211790 | DX-D Imaging Package with XD Detectors | Agfa N.V. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1988 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 3 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2009 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2025 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MQB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MQB device
- #1 K201528 Yushan X-Ray Flat Panel Detector with DROCscore 21.5 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K122866 | Vivix-S with VxvueSummary page 4…Device Class: 2 4. Identification of Predicate Device(s) [21 CFR 807.92(a) (3)] Primary Predicate Device: x M 0WODGT K122866 Product Code: MQB Applicant: Vieworks Co., Ltd. Trade Name: ViVIX-S wit… | 2013 |
| * | K122865 | Vivix-S WirelessSummary page 5…FXRD-1717SA FXRD-1717SB Decision Date: 01/11/2013 Reference Predicate Device x M 0WODGT K122865 Product Code: MQB Applicant: Vieworks Co., Ltd. Trade Name: ViVIX-S Wirel… | 2013 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K200418 | Vivix-S VW | 2020 | 4 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 35 years and passes through 5 companies; a new generation was cleared every 3.1 years on median.
- 10 of the 25 ancestors have a recall of any class.
- Of its descendants, K200418 (Vieworks Co., Ltd., 2020) has gone furthest, with 4 descendants of its own.
- 1 other device also cites its predicate K122866.
How does its category compare?
All MQB devicesMQB Solid State X-Ray Imager (Flat Panel/Digital Imager): FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · MQB
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MQB
127in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MQB
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MQB
141in 2025
MAUDE reports naming product code MQB, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 13 | 22 | 15 | 25 |
| 2008 | 8 | 15 | 36 | 30 |
| 2009 | 15 | 57 | 19 | 34 |
| 2010 | 11 | 116 | 14 | 39 |
| 2011 | 24 | 102 | 10 | 101 |
| 2012 | 22 | 80 | 8 | 267 |
| 2013 | 21 | 105 | 6 | 159 |
| 2014 | 32 | 102 | 0 | 29 |
| 2015 | 21 | 81 | 0 | 21 |
| 2016 | 22 | 92 | 0 | 26 |
| 2017 | 31 | 30 | 1 | 20 |
| 2018 | 16 | 30 | 4 | 84 |
| 2019 | 22 | 30 | 1 | 45 |
| 2020 | 19 | 28 | 4 | 9 |
| 2021 | 21 | 48 | 1 | 26 |
| 2022 | 31 | 48 | 0 | 13 |
| 2023 | 10 | 30 | 0 | 51 |
| 2024 | 8 | 187 | 0 | 91 |
| 2025 | 8 | 127 | 1 | 141 |
| 2026 | 3 | 245 | 1 | — |
What is it indicated for?
VIVIX-S 1012N (FXRD-1012NA, FXRD-1012NB, FXRD-1012NAW and FXRD-1012NBW) is indicated for digital imaging solution designed as a general radiographic system for human anatomy. It is intended to replace film or screen based radiographic systems in all general purposes of diagnostic procedures. It is not to be used for mammography.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K152855 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152855: Vivix-S 1012N.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152855
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026